OncoMatch/Clinical Trials/NCT04569747
A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer
Is NCT04569747 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pertuzumab+TRASTUZUMAB and ADJUVANT ENDOCRINE THERAPY for her2-positive breast cancer.
Treatment: Pertuzumab+TRASTUZUMAB · ADJUVANT ENDOCRINE THERAPY — This research study is studying a combination of HER2-directed therapies (trastuzumab and pertuzumab) and hormonal therapy as a treatment after surgery for hormone receptor positive breast cancer. The study drugs involved in this study are: * A combination of trastuzumab and pertuzumab given as an injection under the skin (PHESGO) * Hormonal (endocrine) Treatment
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) amplification (HER2-positive by ASCO CAP 2018 guidelines)
HER2-positive by ASCO CAP 2018 guidelines
Required: ESR1 expression ≥10% (ER ≥10%)
Either ER or PR must be positive, defined as ER ≥10% or PR ≥10%
Required: PR (PGR) expression ≥10% (PR ≥10%)
Either ER or PR must be positive, defined as ER ≥10% or PR ≥10%
Disease stage
Required: Stage N1MI (AJCC 8th edition anatomic staging table)
HER2-positive T1 histologically confirmed invasive carcinoma of the breast. Patients must have node-negative (N0) or micrometastases (N1mi) breast cancer according to the AJCC 8th edition anatomic staging table.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: definitive breast surgery — current malignancy
Patients must have undergone definitive breast surgery for the current malignancy. All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy (lumpectomy), with either a sentinel node biopsy or axillary dissection
Cannot have received: neoadjuvant or adjuvant chemotherapy
Neoadjuvant or adjuvant chemotherapy for this breast cancer prior to enrollment is prohibited.
Cannot have received: hormonal therapy
Exception: up to 8 weeks of hormonal therapy as adjuvant treatment for this cancer allowed; hormonal therapy administered for less than 8-week duration at least 15 years ago is allowed
Patients should otherwise not have received prior hormonal therapy with the exception that hormonal therapy administered for less than 8-week duration at least 15 years ago is allowed.
Lab requirements
Blood counts
ANC ≥ 1000/mm3; hemoglobin ≥8 g/dl; platelets ≥ 75,000/mm3
Kidney function
Serum creatinine ≤ 2.0 mg/dL OR calculated GFR ≥ 30mL/min
Liver function
AST and ALT both <5x institutional ULN; Total bilirubin ≤ 1.5 mg/dL. For patients with Gilbert syndrome, the direct bilirubin should be <institutional ULN
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 50%
Participants must have normal organ and marrow function as defined below: * ANC ≥ 1000/mm3 * hemoglobin ≥8 g/dl * platelets ≥ 75,000/mm3 * AST and ALT both <5x institutional ULN * Total bilirubin ≤ 1.5 mg/dL. For patients with Gilbert syndrome, the direct bilirubin should be <institutional ULN * Serum creatinine ≤ 2.0 mg/dL OR calculated GFR ≥ 30mL/min Left ventricular ejection fraction (LVEF) ≥ 50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Stamford Hospital · Stamford, Connecticut
- University of Miami- Sylvester Comprehensive Cancer Center · Miami, Florida
- Winship Cancer Institute at Emory University Hospital Midtown · Atlanta, Georgia
- Emory University - Winship Cancer Institute · Atlanta, Georgia
- Winship Cancer Institute at Emory Saint Joseph's Hospital · Atlanta, Georgia
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